Recall of 8596SC: Intrathecal Catheter Pump Segment Revision Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implanted Infusion Pump - Product Code LKK
  • Reason
    The sc catheters cannot completely engage with the model 700-04m portal connector. the result of this condition is a possible leakage or disconnect of the sc catheter from the portal during the continuous therapy trial period.
  • Action
    Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.


  • Model / Serial
    All lots numbers included
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    International Distribution --- country of Belgium.
  • Product Description
    Model 8596SC Intrathecal Catheter Pump Segment Revision Kit || Medtronic Inc., Minneapolis, MN 55432 || A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
  • Manufacturer


  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source